Medical organisations criticise restrictions on France’s Encephalitis vaccine and on its ‘American cousin’
The European Society of Paediatric Oncology (ESPO) has criticised the latest regulations that limit the use of drugs against coronavirus, or cammo, in Europe, saying they have the potential to impact on patients’ lives.
The authorities in Austria, Italy, Croatia and France have placed conditions on their use, following a World Health Organisation recommendation to restrict access to the vaccine Encephalitis A.
Encephalitis A is the causative agent of encephalitis, a neurological disease that affects more than 100,000 people worldwide. There are varying levels of risk, depending on a number of factors, including whether a person has had exposure to cammo.
People exposed to the virus can suffer mild encephalitis if a nasal infection becomes chronic, followed by severe inflammation and damage to the brain. In severe cases the virus can cause encephalitis, or inflammation of the brain, and extensive brain damage, brain death or even death.
In Italy, a draft health law regulating access to the vaccine approved in December has been modified to introduce a restriction for people who have had a previous heart attack or a high number of heart events. If a person has had all three the new rules restrict access to the vaccine in two years.
The ESRO says this should be loosened because there is no evidence to show that the vaccine is “unnecessarily risky” in patients with severe disease.
In Italy, patients have limited access to the vaccine following a phase II trial that showed the vaccine protected adults against up to 20%, versus their gladiator vaccine. Italy’s public health agency, Annozero, says the data is “insufficient” for the country’s broader population.
“ESA requires a dose for adults with patients with severe illness who cannot be vaccinated with other means. If this dose is not available, then a reduction of 25% in total dose is allowed,” Annozero says.
The Italian vaccine programme director, Gabrielle D’Avolio, told the Corriere della Sera newspaper the recommended dose was to be 30% less than people have had in the past.
In Austria, flu-stricken children who have no symptoms can no longer have access to the vaccine due to an order issued by the Tyrolanholmen regional health authority.
Austria’s health minister, Marie Dayan, said the restriction was not discussed by the government and that she would not introduce a national licence if it had been.
The Bulgarian regional health authority has prohibited access to the vaccine because patients who have had serious heart conditions have had insufficient protection.
A ban in Croatia was reversed after it was revealed that results in a small number of patients were invalid and infections were not to blame.
Hanspeter Stöckle-Schör, research director at the institute of epidemiology and paediatrics at Copenhagen University Hospital in Denmark, said: “It’s unfortunate that some governments are enacting stricter regulation to implement the WHO recommendations. We should not stigmatise these patients who have suffered from encephalitis A. We need to support them.”
The WHO recommends that countries test for factors that could increase the risk, such as a high risk of an infection in a child or adult, or the presence of other infections. It also suggests holding special meetings of experts to discuss treatment and policy options.
The ESPO says that restrictions in Europe, including Italy, and in other countries that have developed their own protocols to regulate access to the vaccine, are causing “distress” among paediatricians and risk these guidelines being overturned.